Status:
COMPLETED
Exploratory Study of Iocide Oral Rinse in a Diabetic Population
Lead Sponsor:
Biomedical Development Corporation
Collaborating Sponsors:
Methodist Healthcare Ministries of South Texas
Foundation Of Collaborative Unique Science (FOCUS)
Conditions:
Diabetes Type 2
Periodontitis
Eligibility:
All Genders
35+ years
Phase:
PHASE1
Brief Summary
The goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-susceptible d...
Detailed Description
This double-blind prospective pilot study will evaluate the effects of an investigational oral rinse as an adjunctive agent to non-surgical periodontal intervention for patients with type 2 diabetes m...
Eligibility Criteria
Inclusion
- Have self-reported type 2 diabetes of more than three months duration.
- A current HbA1c value between 7.0% and 12%.
- Report no change in diabetes-related medications during the three months prior to enrollment.
- Be at least 35 years of age.
- Have at least 16 natural teeth.
- Have moderate to severe chronic periodontitis, defined by loss of clinical attachment of \>5 mm on two seperate teeth, and no treatment within six months.
- Able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol
- Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures
- Females with childbearing potential must have a negative pregnancy test before and during the study period. Sexually active females must be using an effective form of birth control. These methods include oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant®), medroxyprogesterone acetate injections (Depo-provera®) or contraceptive foam with a condom.
Exclusion
- History, or current evidence, of any significant acute or chronic medical or psychiatric condition that, in the opinion of the Investigator, would render examination difficult or invalid or prevent the subject from active study participation
- TPOab positive
- Baseline serum level of TSH \<0.35 or \>5.5
- Treatment with antibiotic within the three (3) month period prior to the screening examination
- Presence of valvular disease, prosthetic implant, or any other systemic condition requiring antibiotic premedication
- History of thyroid disease
- Purported sensitivity or allergy to iodine
- Known sensitivity or allergy to shellfish
- History of autoimmune disease, or chronic infections such as HIV or hepatitis
- History of cardiovascular disease (heart attack or procedure within the past three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months), unstable angina pectoris or angina pectoris at rest,
- History of renal disease: serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis.
- Gross oral pathology (periodontal disease, rampant caries, tissue damage created by poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the Investigator, could alter the treatment needs during the study
- Current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores
- Presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed
- History of or current alcohol abuse that, in the opinion of the Investigator, could influence the outcome of the study
- History of, or current drug abuse
- Use of concomitant medication that, in the opinion of the Investigator, might interfere with the outcome of the study (e.g. antibiotics, immuno-suppressants, steroids, or therapeutic doses of non-steroidal anti-inflammatory agents, phenytoin, calcium antagonists, cyclosporine or coumadin)
- Concomitant therapy with another investigational drug or device without prior approval from the Sponsor within four weeks prior to Visit 2 (Study Day 1)
- Concomitant endodontic or periodontal therapy other than prophylaxis in the past six (6) months
- Females with childbearing potential with a positive pregnancy test, pregnant or nursing mothers, suspected pregnancy, or intention to become pregnant during the study
- Residence in the same household as a subject already enrolled in the study (inclusion may create blinding and/or compliance issues)
- Unable and unwilling to comply with the informed consent process, to meet study requirements including following instructions on study treatment, and to return for follow-up visits as required by the protocol.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00801164
Start Date
December 1 2008
End Date
June 1 2010
Last Update
February 2 2012
Active Locations (1)
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1
The University of Texas Health Science Center at San Antonio, Dental School
San Antonio, Texas, United States, 78229